Inhaler for multiple dosed administration of a pharmacological dry powder

ABSTRACT

An inhaler for multiple dosed administration of a pharmacological dry powder has a housing with a mouthpiece fitted thereon and a removable protective cap that covers the mouthpiece prior to removal. The mouthpiece may be fitted with or without lip grooves, which aid a user in the positioning and manipulation of the inhaler. The inhaler includes a dosing slide, a carriage, a dosing cavity and a valve shield, all of which are arranged within the housing. Removal of the protective cap initiates dosing, which consists of a dose of a pharmacological dry powder being received in the dosing cavity and then transported to the mouthpiece by means of the dosing slide. Only upon application of a defined minimum intensity of inhalation is the shutter moved by the suctioned valve shield, resulting in the release of the dose for inhalation.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/077,387, filed May 28, 1998, now U.S. Pat. No. 6,182,655,which is a 371 of PCT/CH96/00430, filed Dec. 5, 1996.

AREA OF APPLICATION OF THE INVENTION

The invention relates to a dry powder inhaler with dosed administrationof a medical preparation upon inhalation by the patient. The drypowder—in loose form or pre-dosed units for dispensing—is contained in amedicament reservoir. The invention concerns the generic type ofinhalers in which, upon activation, a defined dose is first of allintroduced from the internal medicament reservoir into the inhalationchannel by means of a portioning mechanism, and from there the patientdraws this defined dose into his airways via a mouthpiece, in a flow ofair generated by aspiration. Inhalation is a proven method of depositingmedicinal agents in the lungs or delivering them to the blood. Thus, inaddition to the devices for atomizing or nebulizing of liquids, forexample by means of air, compressors, ultrasound, liquefied propellantgases (fluorohydrocarbons, fluorochlorinated hydrocarbons), inhalers forpulverulent preparations with dosed portioning were also developed forthe purpose of inhalation.

A defining feature of inhalers is that the active substance particles ofthe medicament are deposited, by inhalation, in a defined dose andparticle size (about 1–6 μm) either in the central or peripheral lungcompartments (topical treatment) or as very small particles by means ofabsorption in the alveolar region into the blood stream of the patient(systemic treatment).

However, micronized particles with the diameter in question here haveextremely poor flow characteristics. This problem is solved by a numberof conventional methods. Thus, powder mixtures are produced with acarrier which generally has a greater particle diameter than the activesubstance, with the active substance particles depositing themselves onthe carrier surface. On the other hand, in the manufacture of softpellets, a large number of active substance particles are massedtogether to form respectively larger particles, the pellets. Under theeffect of force, the pellets split up again into the individual, smalleractive substance particles. During inhalation it should be possible withthe inhaler to detach the active substance particles from the carrier orto break the pellets up again into small particles. Simple swallowing ofthe medicament is completely undesirable. For this reason, specialfunctional demands are imposed on inhalers in principle.

PRIOR ART

EP-A-0 404 454 and EP-A-0 558 879 disclose inhalers for single use. Suchdesigns are appropriate only for special applications, since on the onehand the patient has no control over the correct use, i.e. the optimuminhalation, and on the other hand a new inhaler has to be used for eachinhalation, which is costly, inconvenient and not environmentallyfriendly.

Thus, inhalers with a dry powder as medicament were developed also formultiple use. WO 93/03782 discloses an inhaler with a medicamentreservoir and a dosing mechanism, by means of which the medicament isconveyed in doses from the storage container into the inhalation channeland can be sucked from there with the flow of air generated by thepatient. This inhaler does not yet satisfy all the requirements. Theexact and prescribed use can still not necessarily be sufficientlyguaranteed. The dosing accuracy has to be increased; humidity too easilypenetrates into the inhaler, the deagglomeration and atomization have tobe improved, and keeping the inhaler clean is complicated.

U.S. Pat. No. 5,239,992 discloses a further inhaler in which a dosingcavity is present in a longitudinally displaceable piston rod and thisdosing cavity, first positioned under the medicament reservoir, receivesa dose of medicament. The patient has to inhale counter to the force ofa spring, so that the piston rod moves and the ready-to-use dose can besucked by the patient through suction openings in the guide channel ofthe piston rod. In principle, this inhaler too exhibits theabovementioned inadequacies.

WO 94/05359 describes an inhaler for multiple dosed administration of apharmacological dry powder which is contained within a medicamentreservoir provided inside the housing. On the inhaler a mouthpiece isjoined which is closed outside inhalations by a folding down protectivecap. The inhaler further has inside a horizontally movable carriage witha dosing depression. If the protective cap is closed the dosingdepression is positioned underneath the funnel-shaped outlet of themedicament reservoir, so that dry powder by its gravity should flow intothe dosing depression until it is full if the inhaler is in a verticalposition. One filling of the depression represents one dose.

After a preceding inhalation a spring arranged above a bellows is tensedby closing the protective cap. The bellows is placed on the medicamentreservoir, an air permeable membrane is provided as a separating wall.During opening the protective cap, the locking of the tensed spring isreleased, so an air pressure pulse acts upon the medicament reservoir.This air pressure pulse ought to guarantee that in each case the dosingdepression is properly filled with dry powder. The carriage is moved byfurther opening of the protective cap, so the dosing depression ispositioned within a suction channel. With the inhalation the medicamentdose is sucked out from the dosing depression through the mouthpiece.

The mouthpiece has at one side a flange for joining to the housing ofthe inhaler and has at the other side a suction pipe outwardlytrumped-like opening. A flow channel flows tangentially into the flangewhich channel is connected with the suction channel, where themedicament dose is available in readiness for inhalation. At the flange,tangentially arranged air openings are provided for the purpose ofturbulence of the medicament containing air stream sucked into themouthpiece.

The spring above the bellows again tenses by closing the protection capand the carriage goes back into its starting position, so the dosingdepression is again positioned underneath the funnel-like outlet of themedicament reservoir and the next inhalation cycle can start.

The previously described inhaler and its pertinent mouthpiece shows thefollowing essential disadvantages:

-   -   Independent of the intensity of the inhalation, the medicament        from the dosing depression can be sucked out too low, such that        the medicament particles only insufficiently arrive at their        intended position within the patient's respiratory ducts and/or        actually only a part of the dose available is sucked out. Thus        the patient has no control as to whether the inhalation has been        actually done or correctly completed.    -   After opening the protective cap and during inhalation, the        inhaler has to be positioned vertically, otherwise the dry        powder can flow back from the dosing depression into the        medicament reservoir or come into the suction channel situated        above the dosing depression and deposit there as a loss. A        construction feature is missing which obligates or requires the        patient to apply the inhaler in the right functional position,        i.e., not in an angled or oblique position in which the        medicament does not flow or flows insufficiently into the        channel inside the inhaler from which the patient inhales the        powder.    -   At least a part of the dry powder of the unused dose can come        into the suction channel if the inhalation is incompletely        finished or not done at all and the inhaler is not held strictly        vertically. By the next inhalation cycle it is metered again,        and therefore inaccuracies of the dosage can emerge. Based on        the construction, double dosages or dosages under the limit can        happen.    -   The extending bellows sucks in a larger amount of external air        with each closing of the protective cap, thereby permitting        moisture to enter the medicament reservoir. This is        disadvantageous for the flowability and the accuracy of metering        of the dry powder as known from the literature and the practice.    -   A further construction feature is missing which guarantees that        the last 5 to 10 nominal doses in the declared measure (weight        and volume) can be delivered in order to solve the        tail-off-problem known of inhalers with a multi dosage        reservoir.    -   The mouthpiece has at its flange a tangentially discharging        channel and openings for acceleration and turbulence of the        airstream generated by the patient. This corresponds with the        cyclone principle as used for a long time for the dry powder        inhalers available on the market (e.g. SPINHALER®,        CYCLONHALER®).    -   The unit for creating turbulence and the mouthpiece can be        cleaned and dried internally relatively poor which under certain        circumstances can cause microbiological problems.

With further focus on the prior art relevant to inhaler mouthpieces,mouthpieces having circular cross-sections had previously been used inthe field, but had the serious disadvantage of potentially reducing theamount of the measured dose of medicament that is to be inhaled by apatient. When extraneous air is permitted into the inhalation channel,the flow of air therein, containing the appropriate measured dose of drypower medicament, is interrupted and the full dose of medicament failsto reach the patient for proper inhalation. Thus, when a patient uses aninhaler, he must snugly encircle the mouthpiece with his lips and insertthe inhaler to prevent extraneous air from entering the inhalationchannel and ensure proper inhalation of the medicament into the upperrespiratory system. In addition, proper rotational orientation of theinhaler and insertion of the mouthpiece a proper distance into thepatient's mouth are also important to maintaining the proper flow anddelivery of the medicament through the inhalation channel to thepatient's mouth.

In order to snugly encircle a mouthpiece having a round cross-section, apatient had to unnaturally constrict or purse his lips, which isdifficult and often failed to prevent entry of extraneous air into theinhalation channel, thus, resulting in failure to receive the properdose of medicament. To address the foregoing problem, mouthpieces withoval shaped cross-sections have been developed to assist the patient inbeing able to snugly encircle the mouthpiece without undue contortion ofthe lips at the sides of the mouth. For instance, patent publicationsEP-B-O 407 028, U.S. Pat. No. 4,227,522 and WO-A-98/30263 discloseinhaler mouthpieces having oval shaped cross-sections.

U.S. Pat. No. 5,622,166, on the other hand, discloses an inhalermouthpiece that is conically tapered towards the patient's mouth butwhich does not address the aforedescribed problem.

Patent publications U.S. Pat. No. 5,320,094, WO-A-97/25086,WO-A-98-26827 and WO-A-98/41256 disclose oval inhaler mouthpieces havingflat or beveled sections on the top and bottom surfaces of themouthpieces. While this configuration may assist the patient in snuglyencircling the mouthpiece with his lips in an airtight manner, thesefeatures do not provide the patient with guidance as to properrotational orientation of the inhaler, nor how far to insert themouthpiece into his mouth for optimal positioning during inhalation.Thus, these problems continue to exist in the existing art.

OBJECT OF THE INVENTION

In summary, it may be stated that none of the inhalers known to date canbe regarded as optimal. The present invention is therefore based on theproblem of producing an inhaler whose functional characteristics areextensively improved. The design construction is intended toconclusively guarantee the prescribed inhalation position and inhalationintensity. In the inhaler there must be a suitable registration andfunction covering a properly completed inhalation, an omittedinhalation, or an incomplete inhalation; in any event, a multiple dosageis to be prevented. It is necessary to improve the dosing accuracy uponpreparation of the individual doses from the medicament reservoir, andthe deagglomeration and atomization of the medicament during inhalation.The protection against humidity is to be made more effective and thecleaning of the inhaler should be made easier. It must be ensured that amouthpiece which has been removed for cleaning is fitted in place againby the patient. The mouthpiece ought to be used as well as in connectionwith the inhaler to be created as with other inhalers of the presenttype. It must also be possible for the inhaler to be manufacturedefficiently as a mass-produced article and at the same time satisfy allthe regulations set forth in drug legislation.

It may, similarly, be stated that the mouthpieces for inhalers foradministration of a medicament, especially a pharmacological dry powder,known to date cannot be considered optimal. Thus, the present inventionhas the object of providing a mouthpiece that facilitates an airtightencircling by the patient's mouth without requiring any special orunnatural efforts to position the patient's lips. At the same time, themouthpiece has to have a configuration that encourages the patient tohold the inhaler in the proper position of rotation and insert themouthpiece into his mouth to the optimal depth. Lastly, it should alsobe possible to dry the cleaned mouthpiece easily, in order to avoidmicrobiological problems which might otherwise appear.

SUMMARY OF THE INVENTION

The inhaler is used for the multiple dosed administration of apharmacological dry powder; it consists externally of a housing and of aprotective cap which can be removed from a special mouthpiece fitted onthe housing. Arranged on the inside there are a slide rail, a dosingslide, a shutter, a carriage, a funnel arrangement, a counter device, avalve shield and a valve guide. Removal of the protective cap initiatesthe dosing, with the dose received in the dosing cavity beingtransported to the mouthpiece by means of the dosing slide. Only uponapplication of a defined minimum intensity of inhalation is the shuttermoved by the suctioned valve plate, as a result of which the dose isreleased for inhalation. Only after a properly completed inhalation canthe dosing slide be returned with its dosing cavity under the funneloutlet for the purpose of preparing for renewed filling.

In the inside of the inhaler there are blocking means which come intoaction as soon as the inhaler, upon removal of the protective cap, issituated in a horizontal and/or axial inclined position going beyond adefined extent. The correct dosing and use position of the inhaler areguaranteed in this way. For the patient's safety, optional blockingmeans can be fitted which prevent any possibility of the protective capof the inhaler being closed when the mouthpiece is missing. This ensuresthat after the mouthpiece has been removed, it is not possible replacingomit to it.

In the mouthpiece, which can be detached from the housing of the rest ofthe inhaler, there is a labyrinthine atomizing path for powderdeagglomeration, in which path there is at least one barrier. For thepurpose of reducing the powder flow rate and depositing relativelycoarse particles ineffective for inhalation, the atomizing pathcomprises, upstream of the channel outlet, a channel section which is ofincreased volume and which deflects the powder aerosol flowing through.The multi-component mouthpiece can preferably be arranged on the inhalerhousing by means of a plug connection and can be opened out afterdetachment from the housing, the mouthpiece parts being connected to oneanother via an integral film hinge.

In an alternative embodiment of the invention, the mouth tube of themouthpiece has a pair of lip grooves that complement one another and aresituated a predetermined distance from the front end of the mouth tube.When the patient holds the inhaler in the proper rotational orientation,the lips grooves are placed in the region of the patient's upper andlower lip. The configuration of the mouth tube and lip grooves helps thepatient achieve an airtight hold on the mouthpiece with his lips so thatthe suction applied by the patient is completely effective to create anaerodynamically medically efficient flow of the medicament to thepatient for effective and full inhalation. Furthermore, the distance ofthe lip grooves from the front end of the mouth tube is that which willresult in the insertion of the mouth tube a sufficient depth into thepatient's mouth so as to prevent the undesired deposition of the drypowder medicament in the patient's mouth and throat. The mouthpieceaccording to the invention is also preferably intended for use with theinhaler according to the invention, but it is also suitable for use inconnection with other inhalers of the same type.

In the inhaler there are means which contribute to the regular flow ofthe pharmacological dry powder when the protective cap is removed. Thegenerated vibrations preferably only exert an effect while the dosingcavity is located under the funnel outlet. These means areadvantageously complementary grate sections which are located oncomponents moved relative to one another.

The inhaler can be supplemented with an electronic module and acontrollable nozzle so that all data relevant to inhalation can berecorded and the flow conditions regulated. Completion of a correctinhalation, or an incomplete inhalation, can be indicated by an acousticand/or optical signal.

BRIEF DESCRIPTION OF THE ATTACHED DRAWINGS

For a better understanding of the present invention, reference is madeto the following detailed description of several exemplary embodimentsconsidered in considered in conjunction with the accompanying drawings,in which:

FIG. 1A inhaler, side view: closed state (starting position→situationA1);

FIG. 1B inhaler, rear view;

FIG. 1C inhaler, front view;

FIG. 1D inhaler, plan view;

FIG. 1E inhaler: protective cap pulled out (intermediateposition→situation A2);

FIG. 1F inhaler, protective cap swung down fully (ready forinhalation→situation A4; inhalation omitted→situation A5; inhalationincomplete→situation A6; inhalation complete→situation A7);

FIG. 2A protective cap, perspective view;

FIG. 2B protective cap, plan view;

FIG. 2C protective cap, side view;

FIG. 2D view into the protective cap;

FIG. 3A lower part of housing, perspective view;

FIG. 3B lower part of housing, plan view;

FIG. 3C lower part of housing, side view;

FIG. 3D lower part of housing, cross-sectional view;

FIG. 3E lower part of housing, perspective view with blocking hooks andballs;

FIG. 3F lower part of housing according to FIG. 3E, plan view;

FIG. 4 upper part of housing, perspective view;

FIG. 5A mouthpiece, perspective view of the base plate;

FIG. 5B mouthpiece, side perspective;

FIG. 5C one half of mouthpiece, external view;

FIG. 5D one half of mouthpiece, internal perspective;

FIG. 5E mouthpiece opened out, internal perspective;

FIG. 6A slide rail, perspective view from below;

FIG. 6B slide rail, side perspective;

FIG. 7A carriage, perspective view from below;

FIG. 7B carriage, perspective view from above, laterally, from thefront;

FIG. 7C carriage, perspective view from above, front;

FIG. 7D carriage, perspective view from above, rear;

FIG. 8A dosing slide, perspective view from above;

FIG. 8B dosing slide, perspective view from above, rear;

FIG. 8C dosing slide, perspective view from below;

FIG. 9A shutter, perspective view from above;

FIG. 9B shutter, perspective view from below;

FIG. 10A valve shield, perspective view;

FIG. 10B valve shield, side perspective;

FIG. 11A valve guide, inner perspective;

FIG. 11B valve guide, outer perspective;

FIG. 12A funnel, perspective view from above;

FIG. 12B funnel, perspective view from below;

FIG. 13A funnel holder, perspective view from above;

FIG. 13B funnel holder, side perspective;

FIG. 13C funnel holder, perspective view from below;

FIG. 14A funnel lid, perspective view from above;

FIG. 14B funnel lid, perspective view from below;

FIG. 14C funnel lid with semi-permeable membrane;

FIG. 15A funnel holder, funnel and funnel lid, side perspective;

FIG. 15B funnel holder and fitted funnel, perspective view from above;

FIG. 16A counter, perspective view of the units wheel;

FIG. 16B counter, perspective view of the hundreds wheel;

FIG. 16C counter, units wheel, outer perspective;

FIG. 16D counter, units wheel, inner perspective;

FIG. 16E counter, tens wheel, outer perspective;

FIG. 16F counter, tens wheel, inner perspective;

FIG. 16G counter, hundreds wheel, inner perspective;

FIG. 16H counter, hundreds wheel, outer perspective;

FIG. 16I counter body, inner perspective;

FIG. 16J counter body, outer perspective;

FIG. 16K counter, cover plate, outer perspective;

FIG. 16L counter, cover plate, inner perspective;

FIG. 16M counter, drive wheel, outer perspective;

FIG. 16N counter, drive wheel, inner perspective;

FIG. 16O engagement of the dosing slide on the counter, units wheel;

FIG. 17A blocking hook, plan view;

FIG. 17B blocking hook, perspective view from right;

FIG. 17C blocking hook, perspective view from left;

FIG. 18A inhaler, horizontal longitudinal section according to FIG. 1Aon line A—A;

FIG. 18B inhaler, vertical longitudinal section according to FIG. 1D online B—B;

FIG. 18C inhaler, vertical transverse section according to FIG. 1D online C—C;

FIGS. 19A to 19D functioning principle of the release of the shutter;

FIG. 19A side wings of the carriage with aperture and cam;

FIG. 19B closed inhaler according to FIGS. 1A and 18A (situation A1);

FIG. 19C shutter close to release, with the protective cap not swungdown fully (situation A3);

FIG. 19D shutter released, with protective cap swung down fully inaccordance with FIG. 1F (situation A4);

FIGS. 20A to 20F functioning principle of the inhaler

FIG. 20A inhaler closed in accordance with FIGS. 1A, 18A and 19B(starting position→situation A1);

FIG. 20B inhaler open in accordance with FIG. 1F and 19D (ready forinhalation→situation A4);

FIG. 20C closing the inhaler (inhalation omitted→situation A5);

FIG. 20D closing the inhaler (inhalation incomplete→situation A6);

FIG. 20E inhaler closed (after incomplete inhalation→situation A8);

FIG. 20F inhaler closed (after completed inhalation→situation A7);

FIGS. 21A to 21C functioning principle of the blocking hooks

FIG. 21A blocking hooks fitted (starting position→situation B1);

FIG. 21B protective cap blocked when mouthpiece missing (incorrectposition→situation B2);

FIG. 21C pivotable protective cap, with mouthpiece fitted (desiredposition→situation B3);

FIGS. 22A To 22B functioning principle of the blocking of the inhaler atan inclined position

FIG. 22A side position of the blocking balls in incorrect positioning ofthe inhaler;

FIG. 22B blocked inhaler;

FIGS. 23A To 23G successive construction of inhaler, persective views:

FIG. 23A lower part of housing with valve shield, valve guide and onemouthpiece half;

FIG. 23B representation in accordance with FIG. 23A, with slide rail andcarriage added;

FIG. 23C representation in accordance with FIG. 23B, with dosing slideadded;

FIG. 23D representation in accordance with FIG. 23C, with shutter added;

FIG. 23E representation in accordance with FIG. 23D, with protective capadded, without lower part of housing;

FIG. 23F representation in accordance with FIG. 23E, with funnel holder,funnel, funnel lid and counter added;

FIG. 23G representation in accordance with FIG. 23F, from the rear side;

FIGS. 24A to 24F alternative embodiment having mouthpiece with lipgrooves;

FIG. 24A inhaler of FIG. 1F showing a mouthpiece with grooves;

FIG. 24B perspective view of the mouthpiece of FIG. 24A showing topgrooves;

FIG. 24C rear perspective view of mouthpiece of FIG. 24B showing thebase plate;

FIG. 24D perspective view of mouthpiece of FIG. 24B rotated 90 degreesclockwise and showing bottom grooves;

FIG. 24E external perspective of mouthpiece of FIG. 24B opened out; and

FIG. 24F internal perspective of mouthpiece of FIG. 24B opened out.

EXEMPLARY EMBODIMENT

In the text which follows, the inhaler according to the invention willbe described in greater detail in terms of its construction, as well asits function, with reference to the attached drawings, and possiblemodifications are mentioned by way of conclusion.

The following statement applies to the whole of the descriptionfollowing. If, for the purpose of clarity of the drawing, referencenumbers are included in a figure but are not explained in the directlyrelevant text of the description, then reference is made to theirmention in preceding figure descriptions. In the interest ofintelligibility, the repeated designation of components in succeedingfigures is for the most part omitted if is it clear from the drawingsthat the components concerned are “recurring” components.

FIGS. 1A to 1D

Externally, the inhaler according to the invention is made up of lowerpart 100 of the housing, the upper part 150 of the housing, and theprotective cap 950. The lower part 100 of the housing and the upper part150 of the housing have an elongate, semi-monocoque configuration. Theupper part 150 has, on its top side, a fairly large opening 151 forreceiving a funnel lid 680, and a window 152 through which the status ofthe counter can be read off. The lower part 100 of the housing and theupper part 150 of the housing are joined to one another such that ahousing is obtained which is in principle closed. Grip contours 951 areprovided on the outside of the protective cap 950 to permit bettergripping. Grip contours, preferably designed as grip dimples 113, arealso arranged on both sides of the housing, in this case extending overthe lower part 100 of the housing and the upper part 150 of the housing.

On the top of the protective cap 950, towards the outer edge, there isan elongate recess, by which means a clearance 968 is created togetherwith the adjoining upper part 150 of the housing. By looking into thisclearance 968 it is possible to ascertain if the mouthpiece is fittedand the clearance 968 is thus filled, or if the mouthpiece is missingand the clearance 968 is consequently open. Opposite the protective cap950—on the rear part of the inhaler—the perforated base 854 of the valveguide enclosed by the lower part 100 of the housing and upper part 150of the housing can be seen.

In the closed state shown here, the starting position—subsequentlyreferred to as Situation A1—the protective cap 950 is fitted flush withthe lower part 100 of the housing and the upper part 150 of the housing.Thus, the medical preparation stored in the inhaler is protected quasihermetically from external humidity.

FIG. 1E

The inhaler has to be opened before use; to do this, the protective cap950 is first of all pulled out in the axial direction. The line alongwhich the protective cap 950 is pulled out is limited by a pair of sidearms 960 which are fixed on the protective cap 950 and engage in alongitudinally displaceable manner in the inside of the inhaler. Withthe protective cap 950 pulled out this far, the mouthpiece 900 isalready partly visible, and is attached to the lower part 100 of thehousing and the upper part 150 of the housing at the front and isenclosed on both sides by the side arms 960. As will be explained later,this step is associated with a temporary vibration for exact dosing ofthe medicament from the powder reservoir. This intermediate position,with the protective cap 950 pulled out, is hereinafter referred to asSituation A2.

FIG. 1F

In order to allow the patient access to the mouthpiece 900, i.e. topermit inhalation, the protective cap 950 suspended on the side arms 960has to be swung down in a further maneuver. The mouthpiece 900 with themouth tube 920 protruding from the base plate 910 is now fully visible.The channel outlet 922 through which the patient inhales the medicamentis situated on the end face 921 of the mouth tube 920.

In this position, with the protective cap pulled out and swung fullydown—subsequently referred to as Situation A4—the inhaler itself isprepared for inhalation. The dose of medicament which has been madeready is in a loosened state. It should be understood that theprotective cap 950 can only be swung down when it has first been pulledout to the limit. The dimensioning of the mouthpiece 900, the length ofthe side arms 960, and the sole possibility of swinging the protectivecap 950 downwards, cause the patient by necessity to place the inhalerin the correct position. If the inhaler were used upside down in error,the patient would notice this immediately since his nose would hitagainst the protective cap 950 and he would thus barely be able to applythe mouthpiece 900.

Situation A3 characterizes the state in which the protective cap 950 isin its swing movement and has not yet reached its lowest position.

FIGS. 2A to 2D

The protective cap 950 consists of the two aforementioned side arms 960and the actual cap 952. The clearances 968, which provide space for thebase plate 910 of the mouthpiece 900, are arranged on that edge of thecap 952 facing towards the mouthpiece 900, centrally on the top side andbottom side.

The two side arms 960 each extend laterally into the cap 952. At thefront part, which engages in the inhaler, the side arms 960 have aspecial construction symmetrical to one another. Each side arm 960 has asquare, rounded aperture 961, a pin 962 lying below the rounded aperture961 and directed inwards, a recess 963 incorporated from the undersideof the side arm and having a cut edge 964, as well as forward bevels969. Between the aperture 961 and the cut edge 964 in each side arm 960there is a further rectangular aperture 970. Offset above this aperture970 there is an outwardly directed dimple 971. The same type of dimple972 is arranged in the lower area of the side arm 960 near the entry tothe cap 952.

FIGS. 3A to 3D

The lower part 100 of the housing has, on both sides, a plurality ofstop cams 101 spaced apart from one another and projecting above theside wall. To the rear, the lower part 100 of the housing isstrengthened at the end, so that a semicircular bearing ring 102 isobtained. A double wall 103, likewise semicircular and with a radialreceiving groove 104, is provided on the base at a distance from thebearing ring 102. Running centrally between the double wall 103 is araised, axial connecting web 115.

Arranged on the base are two parallel bars 106 which extend from thefront side 105 and which each have an outwardly facing indentation 116in the rear area and an obliquely cut aperture 117 in the front area.Together with two columns 118 lying opposite one another at a distance,and a rail 119 extending along the wall of the lower part 100 of thehousing, the indentation 116 delimits a depression-like ball socket 108.There is also an indentation 120 provided in the rail 119, and theindentations 116,120 of identical form lie opposite one another. Thecolumns 118 have points 121 which are directed towards one another andwhich at their deepest point are located in the ball socket 108. On eachof the rear columns 118 there is an inwardly pointing hook 122. A raisedplug 123 is in each case arranged in front of the front pillars 118,facing towards the front side 105. At the front side 105, two receivingnotches 109 are incorporated, as well as two axially extendinglongitudinal slots 110 in the base—near each housing wall. A safety cam125 sits to the side at the entrance of each longitudinal slot 110.Between the two bars 106 and the front side 105 there are two U-shapeddepressions 124.

FIGS. 3E and 3F

In the completed state, a blocking ball 130 lies in each ball socket 108and, with the inhaler in the correct position, this blocking ball 130 islocated at the deepest point between the points 121 of the columns 118.When the inhaler is in an excessively horizontal or axial inclinedposition, the blocking balls 130 roll into the indentation 116 of thebar 106 or into the indentation 120 of the rail 119 and effect ablocking of the inhaler, as described in FIGS. 22A and 22B.

To ensure that the removed mouthpiece 900 is put back in place beforethe inhaler is closed, blocking hooks 140 are optionally fitted on theplugs 123. A blocking hook 140 consists of a spring arm 142 and a lever143 with a laterally protruding blocking tooth 144 and the catch 145pointing to the front side 105. The spring arm 142 of a blocking hook140 passes through the aperture 117, while the lever 143 is pressedoutwards by the tensioning of the spring arm 142, so that its blockingtooth 144 protrudes into the course of the longitudinal slot 110 where,in the completed state, the respective side arm 960 of the protectivecap 900 sits. The function of the blocking hooks 140 is described indetail in FIGS. 21A to 21C.

FIG. 4

Complementing the stop cams 101, the upper part 150 of the housing hasplug holes 153 on its side walls. Analogously to the lower part 100 ofthe housing, the upper part 150 of the housing also has a semicircularbearing ring 154 to the rear, as well as a double wall 155 with areceiving groove 156. The half bearing rings 102 and 154, respectively,and the receiving grooves 104 and 156 combine to form full circles.

On the side walls, mounted ahead of the receiving groove 156, there arein each case a support cam 158 and a higher overspring rib 157. Thesupport cam 158 and the overspring rib 157 project towards the center ofthe upper part 150 of the housing and have a common point of origin onthe side wall. Adjacent to the window 152, two parallel supports 159spaced apart from one another are arranged on the interior of the upperpart 150. In the interior of the upper part 150 there is also the recess151 for the funnel which is to be fitted. On both sides of this recess151, towards the side walls, a limit cam 164 in each case stands outfrom the interior of the upper part 150.

Corresponding to the longitudinal slots 110 in the lower part 100 of thehousing, there are also two slots 161 in the front side 160 of the upperpart 150 of the housing. In the front side 160 there is additionally acentral receiving notch 162, and two elastic clamping prongs 163 extendfrom the front side 160 in the direction of the mouthpiece 900. Across-piece 165 stretches between the front side 160 and the base of theclamping prongs 163, and adjacent to the receiving notch 162. To therear of the front side 160, the clamping prongs 163 merge into avertical U-profile 166, the vertical grooves 167 of the U-profiles 166internally adjoining the front side 160 and facing one another.

FIGS. 5A to 5E

The mouthpiece 900 consisting of the base plate 910 and the mouth tube920 is advantageously made of two halves which are joined together, forexample, by an integral film hinge 923 provided on the end face 921. Onthe base plate 910, facing the inhaler, there is a full connector plug911 at the bottom of each half, and a half-cam 912 at the top, whichcomplements the adjacent half-cam 912. Each connector plug 911 has atits front free end, in the lower area, a recess 930 with an inwardlydirected bevel 931.

Incorporated underneath the two half-cams 912 is an engagement opening913 which extends as a shaft 932 right into the mouth tube 920. Deeperin the shaft 932, a recessed groove 933 is present in each caselaterally in the wall of the mouth tube 920. The channel inlet 914 forthe atomizer path 924 of the mouth tube 920 lies below the engagementopening 913. The channel inlet 914 is connected to the channel outlet922 via the atomizer path 924. A horizontal ramp 935, complementing thesecond half of the mouthpiece, is in each case arranged on the baseplate 910 under the channel inlet 914.

Inside the atomizer path 924, behind the channel inlet 914, there are aplurality of baffles 925 which protrude into the atomizer path 924 forimpacting the medicament-containing air stream and causing it to swirl,so that the atomizer path 924 acquires a course which is rich in curves.Nearer the channel outlet 922, the powder aerosol flowing through entersvia an S-curve into an enlarged channel section 928 and is heredeflected to the channel outlet 922. The purpose of the specialconfiguration of the atomizer path is to deagglomerate the powder and toreduce the flow rate of the powder so as to deposit coarser particleswhich are ineffective for inhalation. At the same time, the impacting ofparticles of active substance in the pharynx of the patient is thusprevented. The mouth tube 920 is flattened off horizontally, at least inthe area of the end face 921, so that the patient is induced to employthe correct positioning of the inhaler during use.

FIGS. 6A and 6B

The slide rail 200 has two longitudinal grooves 202 which extendlaterally from the end face 201 and parallel to one another, and whichreach to approximately halfway along the slide rail 200. In acontinuation of the end face 201, two feet 204 spaced apart from oneanother extend downwards from the bottom of the slide rail 200. At thetop, the slide rail 200 has a ledge-like roof part 210 which protrudesover the end face 201 in the manner of a projecting roof. At theopposite end from the end face 201, the slide rail 200 ends in a slopingsurface 205 which merges ramp-like with the top surface of the sliderail 200, the roof part 210 ending in front of the sloping surface 205.

FIGS. 7A to 7D

The carriage 500 has two wings 503,523 rising laterally and beginning onthe front side 501, with an outwardly directed cam 504 being in eachcase arranged thereon. The cam 504 is wider in the horizontal than inthe vertical, so that an approximately oval shape is obtained. Anarcuate aperture 505 is incorporated in the wings 503,523 and runs roundthe cam 504 from below in a part circle. At its rear side 507, thecarriage 500 has two laterally rising struts 508,510, the strut 508having a horizontal shoulder 509. Two pull cams 512 rise from thecarriage base 511, while to the rear side 507 the carriage base 511continues in the form of two elastic spring tongues 513 which end asspring wedges 514 and can be deflected out to the sides. Between the twospring tongues 513, a longitudinal groove 520 extends centrally throughthe carriage base 511. A pull catch 521 is present on the front side 501between the groove 520 and each of the wings 503,523. Towards the frontside 501, the wing 523 has a grate section 515 on the inside.

Underneath the groove 520, the carriage 500 has two runners 522 on itsunderside. Also on the underside of the carriage, towards the outside asviewed from the runners 522, there are two pairs of impact ridges 524which correspond to the two ball sockets 108 in the lower part 100 ofthe housing. The two impact ridges 524 of one pair are arranged at adistance from one another. A stepped bulge 516 is positioned ahead ofeach pair of impact ridges 524, in the direction of the front side 501.

FIGS. 8A to 8C

Near its front edge 301, the tongue-like dosing slide 300 has athrough-bore, the dosing cavity 302. Starting from the front edge 301,the dosing slide 300 extends firstly as a narrow tongue tip 303 and thenwidens to the rear part 304. A spring leaf 305, from which a cam 306rises perpendicularly, is arranged on the outside flank of the rear part304.

On the underside, the dosing slide 300 has flank ridges 307 which beginimmediately behind the dosing cavity 302 and there form limit stop edges308. The dosing cavity 302 is surrounded by a radial sealing rim 320 onthe underside. Near the transition to the rear part 304, there are twodownwardly extending transverse cams 309. On the rear edge 310 of thedosing slide 300 there are two downwardly directed, profiled catches321.

FIGS. 9A and 9B

The shutter 400 has the function of releasing the medicament made readyin the dosing cavity 302 only when there is a suitably forcefulinhalation. At the very front, the shutter 400 has a sleeve-like closurepart 401 with the through-opening 402. Behind the closure part 401 thereare outer, vertical side ridges 403, beginning with a limit stop 404. Anoutwardly directed and ramp-shaped wing 405 is arranged on each sideridge 403. In the direction of the rear part 406, the wing 405 isfollowed by a side bracket 407. At the bottom, on the rear edge 408, theshutter 400 also has an outwardly directed carrier 409. On the bottom,in the area of the wings 405, two base plates 410 extend towards oneanother, leaving a through-gap 411. Towards the rear edge 408, the endof the rear part 406 is provided with a cover 420 which at the topstretches across the two parallel side ridges 403 and beginsapproximately in the area of the side brackets 407. In the cover 420there is a rounded-off groove 421 which extends along the middle andwhich is open to the center of the shutter 400.

FIGS. 10A and 10B

The valve shield 800 has the function of inducing the patient togenerate a defined minimum suction for a correct inhalation. The valveshield 800 consists of a cylindrical capsule 810 and a plurality of armsattached thereto and having different tasks. The capsule 810 has aflange-like collar 811 surrounding the opening and protruding outwards.The bottom 812 of the capsule 810 is convexly curved outwards and has alarge number of raised stubs 813 on the outside.

The further elements of the valve shield 800 are attachedperpendicularly onto the collar 811 extend in the axial direction. Onthe collar 811 there is firstly a pair of long tentacles 820 which lieopposite one another and which have carriers 821 at their very front.Before the tentacles 820 there are two shorter spring arms 822 withoutwardly directed wedge profiles 823 at their tips. Behind thetentacles 820 there are two further spring arms 825 with outwardlydirected hooks 826. Between these spring arms 825 there are two shortlocking teeth 824 standing close to one another.

FIGS. 11A and 11B

The capsule-shaped valve guide 850, when fitted into the lower part 100of the housing and the upper part 150 of the housing, serves to receivethe valve shield 800, i.e. its capsule 810. To this extent the valveguide 850 has the function of a slide bearing. Complementing the collar811 of the valve shield 800, the valve guide 850 has an external limitstop flange 851. Slide ribs 852 in the inside of the valve guide 850have the purpose of reducing the friction as the valve shield 800travels out. The perforated bottom 854 has numerous holes 855, so thatthe stubs 813 of the valve shield 800 find space therein. At the top andbottom of the limit stop flange 851 there are two diametrically oppositenotches 856. The holes 855 and the stubs 813 make it possible to designthe inhaler virtually closed at the rear and thus to prevent thepenetration of dirt particles and the inadvertent displacement of thevalve shield 800.

FIGS. 12A and 12B

The funnel 690 is intended for fitting into the funnel holder 601 (seeFIGS. 13A,13B). The funnel bottom 691 is designed sloping obliquelytowards the outlet 692, so that the medicament powder flows in afavorable manner. The outlet 692 is surrounded on the outside by asealing element 694. On the outside, the funnel 690 has retainer cams695 projecting upwards on two opposite sides, as well as a centrallypositioned fixing nose 696 which sits on the oblique funnel bottombetween the retainer cams 695.

FIGS. 13A and 13B

The box-shaped funnel holder 601 has, on the underside, the holderbottom 603, the front wall 611, the rear wall 612, and the twohalf-height side walls 613,614 lying between the front and rear walls611,612. Located in the holder bottom 603 are the funnel outlet 608 andan elongate groove 615. At the very bottom, a sealing member 622surrounds the funnel outlet 608, so that it is possible to prevent theentry of humidity and the escape of powder from the funnel 690 onto thesliding surfaces of the dosing slide 300.

Arranged perpendicularly on the front wall 611 are two angled rails 616,and at the top of the rear wall 612 there is a support edge 602, fromwhich a spring arm 617 in each case extends along the two side walls613,614. A groove 618 facing the respective side wall 613, 614 isprovided in each of the spring arms 617. The side walls 613,614 eachhave a downwardly open notch 619 approximately at their center on thelower edge. A grate section 621 is provided on one side wall 613 nearthe rear wall 612. Two elastic lamellae 605 are connected to the rearwall 612 and extend along the outer flanks of the holder bottom 603, thelamellae 605 have vertically movable ends with downwardly projectingblocking cams 609.

FIGS. 14A to 14C

The funnel lid 680 serves to close the funnel 690. On the underside ofthe funnel lid 680 there is a chamber 681 which is closed by asemi-permeable membrane 682. The chamber 681 is intended to receive amoisture-attracting desiccant powder and the moisture can diffusethrough the semi-permeable membrane 682.

FIGS. 15A and 15B

When the funnel arrangement is in its completed state, the funnel 690 isfitted into the funnel holder 601, and the funnel 690 is closed by thefunnel lid 680. However, the sequence of assembly of the inhaler neednot include the prior completion of the funnel arrangement.

FIGS. 16A and 16B

The complete counter 700 consists of the units wheel 701, the tens wheel780, the hundreds wheel 720, the counter body 740, the counter coverplate 760, and two identical drive wheels, which are not shown here. Thepurpose of the counter 700 is to register the number of doses used ordoses still available and to indicate to the patient the inhalationwhich has just taken place, as long as it was performed correctly.Numbers and, if appropriate, a color marking are provided on thecircumference of the counter wheels 701,780 and 720 fixed on the axle741 of the counter body 740. The current status of the counter isdisplayed under a lens 742 which sits in the window 152 of the upperpart 150 of the housing. The lens 742 is connected to the counter body740.

FIGS. 16C and 16D

The units wheel 701 has ten radially distributed cams 703 on its outersurface 702.

FIGS. 16E and 16F

The tens wheel 780 with its inner toothed ring 781 is itself of aconventional construction.

FIGS. 16G and 16H

The hundreds wheel 720 likewise has an inner toothed ring 721 and anoutwardly protruding end cam 722.

FIGS. 16I and 16J

The counter body 740 consists of the base plate 743, the lens 742 set onthe top at right angles, the axle 741 extending perpendicularly from thebase plate 743, as well as the drive-wheel bearing 744.

FIGS. 16K and 16L

Bearing on the units wheel 701, the counter cover plate 760 is fixed onthe axle 741 of the counter body 740. The counter cover plate 760 has anelastic adjusting tongue 761 with a wedge cam 762 at the end, which cam762 moves at all times between two cams 703 of the units wheel 701.

FIGS. 16M and 16N

The star-shaped drive wheel 790 is fitted on the one hand between theunits wheel 701 and the tens wheel 780 and on the other hand between thetens wheel 780 and the hundreds wheel 720. It has six uniformly arrangedteeth 791, of which every second tooth 791 has an undercut 792 at itstip on one side of the drive wheel 790.

FIG. 16O

When a correct inhalation has been completed and the inhaler has beenclosed again by swinging the protective cap 950 upwards and pushing itin, the actuation of the counter 700 takes place. Only on pushing thedosing slide 300 back into the starting position—Situation A1—is a cam703 on the units wheel 701 gripped by the cam 306 situated on the springleaf 305, and the units wheel 701 thereby turned by one count position.

When the intended number of doses have been taken from the inhaler, thehundreds wheel 720 is in such a position that the end cam 722 haspositioned itself at the far top and, on pulling the carriage 500 out,the shoulder 509 (see FIGS. 7A to 7D) strikes against the end cam 722.Further actuation of the inhaler is thus blocked.

FIGS. 17A to 17C

As an option for increasing the safety of handling of the inhaler, tworotationally movable blocking hooks 140 are provided which can befastened onto the plugs 123 in the lower part 100 of the housing. Theblocking hook 140 is two-armed and is divided into a thin spring arm 142and a more solid lever 143, the spring arm 142 spreading away from thelever 143. The blocking hook 140 has a bore 146 so that the blockinghook 140 can be fastened onto the plug 123. On the lever 143 there is ablocking tooth 144 protruding out to one side and pointing away from thespring arm 142, as well as a catch 145 pointing forwards and extendingthe length of the lever 143.

FIGS. 18A to 18C

In the assembled state, the following arrangement obtains in SituationA1. The lower part 100 of the housing and the upper part 150 of thehousing are joined together. The mouthpiece 900 is inserted from thefront and the protective cap 950 is fully closed.

The slide rail 200, the carriage 500, the dosing slide 300, the shutter400 lie in the housing parts 100,150. The valve guide 850 is fitted, andtherein the valve shield 800, as well as the complete funnelarrangement—consisting of funnel 690, funnel holder 601 and funnel lid680—and the counter 700. The valve shield 800 is in its rearmostposition, and the dosing slide 300 is located such that the dosingcavity 302, positioned under the funnel outlet 608, can fill withmedicament. The closure part 401 of the shutter 400 protrudes into thechannel inlet 914. The clamping prongs 163—additionally fixing themouthpiece 900—sit in its shaft 932 and engage in the grooves 933. Thehalf-cams 912 of the mouthpiece 900, joined together, are locked in thereceiving notch 162 in the upper part. 150 of the housing. The connectorplugs 911 of the mouthpiece 900 pass through the receiving notches 109in the lower part 100 of the housing, and the ramp 935 of the mouthpiece900 engages under the front edge of the roof part 210 of the slide rail200. The side arms 960 of the protective cap 950 protrude through theslots 110 in the lower part 100 of the housing and through the slots 161in the upper part 150 of the housing and embrace the wings 503,523 ofthe carriage 500. The pins 962 now hang in the apertures 505, while thecams 504 engage in the apertures 961. To fix the protective cap 950 inthe starting position, the safety cams 125 are locked into the dimples972.

The feet 204 of the slide rail 200 engage in the depressions 124 in thelower part 100 of the housing. The angled rails 616 of the funnel holder601 are driven into the vertical grooves 167 of the U-profiles 166 onthe upper part 150 of the housing. The funnel 690 sits with its retainercams 695 and its fixing nose 696 in the notches 619 and in the groove615, respectively, of the funnel holder 601. The outlet 692 of thefunnel 690 with the sealing member 694 is situated in the funnel outlet608. In addition, the funnel holder 601 is fixed laterally by the limitcams 164 in the upper part 150 of the housing.

The complete counter 700 is held by the supports 159 in the upper part150 of the housing. The capsule 810 of the valve shield 800 sits to themaximum extent in the valve guide 850, the limit stop flange 851 of thelatter sitting in the receiving grooves 104,156 of the lower part 100 ofthe housing and the upper part 150 of the housing, respectively, and theconnecting web 115 coming into engagement with the notch 856.

FIGS. 19A to 19D

This sequence of figures illustrates the release of the shutter 400which surrounds the dosing cavity 302 of the dosing slide 300 filledwith medicament, upon swinging the protective cap 950 down.

FIGS. 19A and 19B

In accordance with Situation A1, the carriage 500 is so positioned thatits wings 503,523 stand before the funnel holder 601, i.e. the pin 962of the side arm 960 of the protective cap 950, engaging in the aperture505, is ineffective as regards unlocking the unmovable shutter 400. Theblocking cams 609 under the funnel holder 601 engage behind the wings405 projecting laterally on the shutter 400. The dosing cavity 302 issituated underneath the funnel outlet 608 and could already be filledwith medicament.

FIG. 19C

The protective cap 950 has in the meantime been pulled out completelyand the carriage 500 hanging on the side arms 960 has been pulledforward; Situation A2 has been reached. The shutter 400 is stillunmovable and, with its closure part 401, surrounds the dosing cavity302 which has been pushed into the channel inlet 914 of the mouthpiece900 by means of pulling off the protective cap 950 and filled withmedicament.

The swinging-down of the protective cap 950 now commenced, i.e.situation A3 is being implemented. However, the protective cap 950 hasnot yet been swung down fully, so that the pin 962 ascends in theaperture 505 during the swinging-down movement and consequentlygradually raises and unlocks the lamella 605 arresting the shutter 400.

FIG. 19D

In situation A3 which has been reached—this also applies to SituationsA4 to A7—the protective cap 950 has been swung down fully, as a resultof which the pin 962 forces the lamella 605 up. The blocking cam 609 isthus disengaged from the wing 405 on the shutter 400. The shutter 400 ismovable, i.e. readiness for inhalation exists in conjunction withsituation A3. The swung-down protective cap 950 is fixed in thisposition by the cooperation of the safety cams 125 in the lower part 100of the housing and the dimples 971 on the side arms 960.

FIGS. 20A to 20F

This sequence of figures illustrates a complete inhalation cycle withthe mechanical events occurring in the different possible situations.

FIG. 20A

In situation A1, the valve shield 800, the carriage 500 and the shutter400 are located in their rear end position. This is the state of theinhaler after the protective cap 950 is closed following a correctlyperformed inhalation or prior to the first use. With the protective cap950 being pushed in, the shutter 400, the valve shield 800 and thedosing slide 300 have been pushed back into the rear end position by thecarriage 500. The pull catch 521 of the carriage 500 grips the carrier409 of the shutter 400. With its spring wedges 514, the carriage 500presses against the catches 321 of the dosing slide 300, the springwedges 514 being enclosed to the inside by the locking teeth 824.

The two struts 508,510 of the carriage 500 have pushed the valve shield800 into its starting position. A cam 703 on the units wheel 701 of thecounter 700 has been put forward one unit by the cam 306 on the dosingslide 300. The dosing cavity 302 is now once again situated underneaththe funnel outlet 608.

FIG. 20B

In situation A4 the inhaler is in a state of readiness for inhalation.By pulling the protective cap 950 out, the valve shield 800 is advancedfrom the rearmost position. The carriers 821 on the tentacles 820 havebeen gripped by the wings 503, 523 and pulled forward slightly, so thatthe stubs 813 of the valve shield 800 are removed from the holes 855 ofthe valve guide 850 and create air gaps. The inhaling patient is able todraw breath through these air gaps if no other air inlets are providedon the inhaler. On pulling the protective cap 950 out, the carriage 500was moved with its grate section 515 past the grate section 621 of thefunnel holder, so that a vibration was generated for promoting the flowof the medicament powder from the funnel 690 into the dosing cavity 302.The grate sections 515,621 are dimensioned and arranged in such a waythat when pulling the protective cap 950 out, vibrations are generatedonly so long as the dosing cavity 302 is situated under the funneloutlet 608. When the carriage 500 begins to pull the dosing slide 300with it, the grate sections 515 and 621 disengage.

The dosing slide 300 was furthermore gripped via the transverse cams 309by the pull cams 512 of the carriage 500 and moved forwards in thedirection of the mouthpiece 900 to such an extent that the dosing cavity302 is now surrounded by the closure part 401 of the shutter 400. Theshutter 400 is also released, since the blocking cams 609 underneath thefunnel holder 601 have lifted from the wings 405 of the shutter 400 asthe protective cap 950 swings down. The wedge profiles 823 of the springarms 822 of the valve shield 800 stand adjacent to the overspring ribs157 of the upper part 150 of the housing.

Pressure is exerted from above on the spring arms 617 of the funnelholder 601 so that all the components lying below are subjected to acertain amount of surface pressure. This increases the tightness andprevents the escape of medicament powder. After the protective cap 950has been swung down, the inhaler is in a state of readiness forinhalation, and the easier mobility of the shutter 400 is now desired.When the side arms 960 are swung down, the surface pressure acting fromabove is in part compensated, as the pin 962 ascending in the aperture505 presses against the lamellae 605. By means of the oval shape of thecam 504 and the geometry of the aperture 961, the cam 504 has adeliberately greater vertical play in the aperture 961 than itshorizontal play. The reduced surface pressure now affords easiermobility of the shutter 400 upon inhalation.

FIG. 20C

In situation A5—the inhaler is closed again after an omittedinhalation—the valve shield 800 remained in its position, i.e. it wasnot sucked forwards. When the protective cap 950 is applied, thecarriage 500 is pushed back; its spring tongues 513 move away from thecatches 321 of the dosing slide 300. The valve shield 800 is againpushed into its rearmost position by the carriage 500; the shutter 400is locked again. The dosing slide 300 remains, however, with its filleddosing cavity 302 in its forward position; it remains there as a resultof suitable friction.

FIG. 20D

In situation A6—inhalation was interrupted when incomplete—the valveshield 800 has not yet reached its forward position, as a result ofwhich the shutter 400 was not yet displaced, and the dose of medicamentremained enclosed. When the protective cap 950 is applied and thecarriage 500 pushed back, the dosing slide 300 remains with itsunemptied dosing cavity 302 at the front. The spring tongues 513 of thecarriage 500 strike via the spring wedges 514 against the catches 321and are thus bent inwards. In this way the spring wedges 514 strikeagainst the locking teeth 824 and thus push the valve shield 800 back,until the further pushing back of the valve shield 800 by the two struts508 and 510 of the carriage 500 takes place.

FIG. 20E

After incomplete inhalation and reclosing of the inhaler—situationA8—the filled dosing slide 300 stands forward, while the valve shield800 and carriage 500 are again situated in the rear starting position.

FIG. 20F

In situation A7—after completed inhalation—the protective cap 950 isswung fully down, as a result of which the pins 962 have lifted thelamellae 605 of the funnel holder 601 and the wings 405 of the shutter400 have been unlocked. During a correct inhalation, the valve shield800 has been sucked forwards. The spring arms 822 with the wedgeprofiles 823 have surmounted the overspring ribs 157 in the upper part150 of the housing as a result of the valve shield 800 moving forwards.The shutter 400 was pushed into its front end position by the advancingvalve shield 800, by which means the dosing cavity 302 became free andthe medicament was inhaled by the patient.

During a correct inhalation the valve shield 800 has been suckedforwards, after its spring arms 822 with the wedge profile 823 havesurmounted the overspring ribs 157. It is possible to define thenecessary suction effort with the geometry of the wedge profile 823 andof the overspring ribs 157, and with the elasticity of the spring arms822. In the frontmost position of the valve shield 800, the two elasticspring arms 825 with the hooks 826 arranged thereon are driven behindthe hooks 122 arranged in the lower part 100 of the housing. Thisprevents the valve shield 800 from automatically sliding back.

During the reverse movement of the carriage 500, its spring wedges 514sit clamped between the catches 321 and the locking teeth 824 and cannottherefore escape. As a result, the dosing slide 300 and the valve shield800 are now pushed back into the starting position—Situation A1—by thespring wedges 514 and the struts 508,510. In so doing, the hooks 826,122are released from one another.

FIGS. 21A to 21C

This sequence of figures illustrates the function of the blocking hooks140 employed in the interaction with the mouthpiece 900 and the sidearms 960 of the protective cap 950.

FIG. 21A

In the starting position B1, the protective cap 950 is closed, i.e.pushed on; the mouthpiece 900 however is absent when fitting theblocking hooks 140. The spring arms 142 protrude through the apertures117 in the bars 106, support themselves therein and force the levers 143outwards. The blocking teeth 144 strike the solid side arms 960 of theprotective cap 950.

FIG. 21B

Here—in the incorrect position B2—the protective cap 950 is pulled outand swung down; the carriage 500 is pulled forward, so that the springarms 142 are pressed back into the apertures 117 by the carriage 500, asa result of which the levers 143 are under increased tensioning. Themouthpiece 900 has been removed, however, for example for a cleaningprocedure. The blocking teeth 144 now engage in the apertures 970present in the side arms 960, since the levers 143 are forced outwardsby the pressure of the spring arms 142. In this state, the protectivecap 950 cannot be swung up in order to push it in. Thus, the absence ofthe mouthpiece 900 is made evident, and this precludes a situation wherethe patient puts the inhaler away without the mouthpiece 900 beingfitted and cannot then use the inhaler in an emergency.

FIG. 21C

In the desired position B3, the mouthpiece 900 is fitted. The connectorplugs 911 of the mouthpiece 900 project into the receiving notches 109.The bevels 931 of the connector plugs 911 here press the catches 145 ofthe levers 143 inwards, counter to the tensioning of the spring arms142, so that the blocking teeth 144 are drawn out of the apertures 970.The protective cap 950 can thus be swung up again and closed.

FIGS. 22A and 22B

With correct positioning of the inhaler, i.e. when there is noover-critical inclination in the horizontal or in the axial axis ofrotation, the blocking balls 130 position themselves centrally in theball sockets 108 at the deepest points. In such a position, theprotective cap 950 can be pulled out, since the appended carriage 500 isnot blocked and can also be moved out.

If the inclination is over-critical, then the blocking balls 130 rollfrom the deepest points onto the lateral limits 116,120 and now liehigher up because of the oblique slopes in the ball sockets 108. Outwardtravel of the carriage 500 is now blocked. The blocking balls 130 nowcome into collision with the impact ridges 524 and the bulges 516, sothat ultimately the protective cap 950 cannot be pulled out. This safetymeasure guarantees that the inhaler is held in the correct position whenit is opened, so that a correct filling of the dosing cavity 302 withmedicament powder is ensured. The inhaler has to be opened in theprescribed position, but it can be used in any position once it has beenopened, that is to say, in particular, also for patients who are lyingdown. A further control on its use is afforded by the fact that theprotective cap 950 can only be swung downwards.

FIGS. 23A to 23G

This series of figures gives an impression of the successiveconstruction of the inhaler, although this need not necessarilycorrespond with the sequence of assembly in mass manufacture.

The valve guide 850 is fitted into the rear of the lower part 100 of thehousing and the valve shield 800 is fitted into the valve guide 850. Themouthpiece 900 projects from the front, only one half of the mouthpiece900 being shown for reasons of improved clarity (FIG. 23A). The inhaleris equipped with the slide rail 200 placed near the mouthpiece 900 andwith the carriage 500 bearing on the valve shield 800 (FIG. 23B). Thedosing slide 300 is now placed on the slide rail 200 (FIG. 23C). Theshutter 400 is added for further completion (FIG. 23D). The protectivecap 950 with the lateral side arms 960, which are attached to thecarriage 500, is now fitted (FIG. 23E). The completely fitted funnelarrangement 600, which is directed towards the protective cap 950, andthe counter 700 are shown here in two views (23F, 23G). Finally theupper part 150 of the housing would have to be fitted.

FIGS. 24A to 24F

An alternative embodiment of the present invention is shown in FIGS. 24Ato 24F. The views shown in FIGS. 24A to 24F are similar to FIGS. 1F and5A to 5E, described earlier, and comprise essentially the same featuresand functionality. Thus, the reference numbers used in figurespreviously discussed are also used in FIGS. 24A to 24F to indicatesimilar features of the alternative embodiment.

The alternative embodiment comprises an improvement, namely, the mouthtube 920 of the mouthpiece 900 has a pair of lip grooves 929 which willbe described in more detail hereinafter. The lip grooves 929 guide thepatient to receive the mouthpiece 900 in the proper position withrespect to rotational orientation and depth of insertion into thepatient's mouth, as also discussed further below. As in theearlier-described preferred embodiment, the mouthpiece 900 of theinhaler is accessed by extending and swinging down the protective cap950 that is suspended on the side arms 960. The mouthpiece 900, nowfully visible, has a base plate 910 and a mouth tube 920 protrudingtherefrom.

The mouth tube 920 has an elliptical cross-sectional shape. When theinhaler is held in the proper rotational orientation, the horizontalwidth of the elliptical cross-section is greater than the verticalheight thereof, which shape and orientation better enables the patientto encircle the mouth tube 922 in an airtight manner with his mouth toensure full and proper inhalation of the dosed medicament. The mouthtube 920 also has a curved exterior surface, a longitudinal axis and anend face 921 with an upper portion on which the channel outlet 922 islocated.

As already described, the patient inhales the dry powder medicamentthrough the channel outlet 922. As with the preferred embodiment, themouthpiece 900 is advantageously made of two symmetrical halves. The twohalves of the mouthpiece 900 are joined together, for example, by anintegral film hinge 923 provided on the end face 921.

As stated above, the mouth tube 920 has a pair of lip grooves 929 on thecurved exterior surface thereof as shown in FIGS. 24A to 24F. Thegrooves 929 are aligned transversely to the longitudinal axis of themouth tube 920 and are spaced opposite one another on the surface of themouth tube 920 to complement one another as follows. When the inhaler isproperly held, one of said lip grooves 929 is on top of the curvedexterior surface of the mouth tube 920 and the other lip groove 929 ison the bottom, so as to align with the patient's lips. The grooves 929are sized and shaped so as to receive the patient's upper and lower lipsand, thus, alert the patient as to the correct rotational orientation ofthe inhaler during use. Such proper rotational orientation of theinhaler ensures efficient operation of the inhaler and inhalation of themedicament by the patient.

Another aspect of the lip grooves 929 is that they are positioned on themouth tube 920 at a predetermined distance from the end face 921. Thepredetermined distance is that which will indicate to the patient theproper depth of insertion of the mouthpiece 900 into the patient'smouth. This insertion of the mouthpiece 900 to a proper depth, coupledwith the location of the channel outlet 922 on the upper portion of theend face 921, provides optimal positioning for the channel outlet 922within the patient's mouth during inhalation. This optimal positioningof the channel outlet 922 prevents undesirable deposition of dry powdermedicament in the mouth and throat, as opposed to optimal deposition inthe patient's lungs.

Further constructional variations can be made to the inhaler which hasbeen described. The following variations are expressly mentioned here:

-   -   Instead of the dimples 972 for arresting the protective cap 950        in the pushed-in state—situation A1—an outwardly directed cam        could in each case be provided near the entrance to the cap 952        on the upper side of the side arms 960, and engage in slots in        the front side 160 of the upper part 150 of the housing in the        closed state. In order to detach the protective cap 950 from the        mouthpiece 900, the protective cap is to be pressed-in in the        area of the lateral grip contours 951, as a result of which the        cams come out.    -   In the mouthpiece 900, near the channel outlet 922, it is        possible to provide in the enlarged channel section 928 a        three-dimensional surface-profiled wall section with a        transverse fluting in order to promote the powder        deagglomeration and the deposition of coarser particles        ineffective for inhalation.    -   To hold the two halves of the mouthpiece 900 together,        complementary connecting elements could be arranged in each case        on the inner cut edges of the two halves—for example, a        combination of bores and cams—in order for both halves to be        joined together again aster possible cleaning and drying.    -   To embed the funnel arrangement in the inhaler, it might be        possible to use a collar made of elastic material which is        pushed onto the funnel holder 601.    -   The pharmacological dry powder stored in the funnel 690 can be        in loose form on the one hand. However, pre-dosed units for        dispensing are also included, for example as an extruded pellet        lane or in pearl chain form. Individually dosed units for        dispensing could be arranged in blisters or on tape rolls. It        will be appreciated that the medicament reservoir and a device        for dividing off the individual doses are to be designed in        accordance with each other.    -   Irrespective of the greater outlay in terms of manufacturing        technology, the above-described two-part housing, consisting of        the lower part 100 of the housing and the upper part 150 of the        housing, could also be made in one piece.    -   The atomizer path 924 in the mouthpiece 900 is designed as a        straight or winding channel in which at least one baffle 925 is        arranged, and the latter can be an inwardly projecting lamella,        a wall, a flow body or a screen.    -   Instead of the mechanical counter 700, it is also possible to        use a chip with which all relevant data are recorded, such as        number of inhalations performed, time of intake, and flow        parameters.    -   The flow control realized at present by means of the overspring        rib 157 and the spring arms 822 could also be obtained by means        of an alterable resistance within the valve guide 850.    -   To regulate the flow rate, it is advantageous to provide an        insert for receiving an optional nozzle within the mouth tube        920, namely at the start of the atomizer path 924 or mounted        upstream of the mouth tube.    -   For specific changing of the flow resistance in the inhaler        during an inhalation, which resistance is obtained by the air        gap between the fixed valve guide 850 and the moving capsule 810        of the valve shield 800, it is possible to configure this air        gap, effective at the respective position of the valve shield        800, incrementally by means of physical irregularities on the        surface of the capsule 810 and/or in the inside of the valve        guide 850. For this purpose, consideration may be given, for        example, to widening or narrowing physical dimensions on the        capsule 810 of the valve shield 800 and in the valve guide 850        or grooves whose cross-section changes along their length.    -   In the inhaler which has been described, but also in inhalers in        general, there is the possibility of recording the inhalations        and their flow parameters by means of sensor technology. To        measure the parameters, use is made of membrane/bending beam        technology or a piezoresistive element in combination with a        diaphragm or in combination with the Venturi measurement        principle. With IPC logic and sensor technology, open-loop        control becomes closed-loop control. This closed-loop control        makes it possible to govern an adjustable nozzle via an        electronic movement element, which nozzle finally regulates the        flow in the inhaler constantly by a resistance change.    -   For current supply, a dynamo is provided in the inside of the        inhaler and generates an electric current when the protective        cap 950 is opened or when air flows through the inhaler during        the inhalation, this electric current being stored and being        used to supply the electronic components.    -   The electronic components, as a plug-in, re-usable control        module, can be removed from the inhaler so that a battery        operation is possible. The inhalation data are collected by        means of an integrated memory chip and made available to the        doctor or pharmacist. Exact monitoring of the dose        administration is thus possible. The plug-in modules can be        recharged on base units for further use and/or can be programmed        so that only the contaminated part of the inhaler is to be        discarded.    -   To better monitor the inhalation procedure, a mechanically        and/or electronically generated acoustic and/or optical signal        is emitted on completion of a successful or unsuccessful        inhalation.    -   It is also possible to arrange the two complementary grate        sections 515,621 on the one hand on the carriage 500 and on the        other hand on the lower part 100 of the housing or on the upper        part 150 of the housing. So that vibrations occur only when the        protective cap 950 is being pulled out—but not when it is being        pushed back—one of the two grate sections 515,621 can be taken        out of operation on each replacement of the protective cap 950,        e.g. on a component which is also movable.    -   The desiccant powder at present accommodated in the funnel lid        680 inside the chamber 681 could also be positioned inside the        funnel holder 601.    -   The outer contours of the inhaler and the internal weight        distribution mean that when it is laid on an essentially        horizontal and dimensionally stable support, the inhaler always        orients itself with the outlet 608 of the funnel holder 601        pointing downwards.

1. A mouthpiece for an inhaler, comprising: a channel inlet; a mouthtube having a channel outlet; and an atomizer path extending within saidmouth tube from said channel inlet to said channel outlet, said atomizerpath including a first channel section having at least one baffle and asecond channel section in communication with said first channel section,said second channel section having a larger volume than said firstchannel section, said mouth tube including a curved exterior surfacehaving a top side and a bottom side; and a pair of lip grooves that aresized and shaped so as to receive the lips of a patient and that arearranged on said curved exterior surface such that one lip groove islocated on said top side and the other lip groove is located oppositesaid first groove on said bottom side, said mouth tube being comprisedof a pair of symmetrical halves, each having corresponding complementaryconnecting elements and being connected to one another by an integralhinge, one of said symmetrical halves having a first groove segment anda second groove segment, and the other of said symmetrical halves havinga third groove segment and a fourth groove segment, said third groovesegment cooperating with said first groove segment to form said one lipgroove, and said fourth groove segment cooperating with said secondgroove segment to form said other lip groove.
 2. The mouthpieceaccording to claim 1, wherein said mouthpiece is adapted for use with aninhaler for administration of pharmacological dry powder.
 3. Themouthpiece according to claim 1, wherein said first channel section ofsaid atomizer path is formed by walls and said walls form said at leastone baffle.
 4. The mouthpiece according to claim 3, wherein said firstchannel section includes a plurality of baffles which protrude into saidatomizer path, thereby forming a plurality of curves within saidatomizer path.
 5. The mouthpiece according to claim 4, furthercomprising a ramp which is positioned at the channel inlet.
 6. Amouthpiece for an inhaler, comprising: a mouth tube having an end facewith an upper portion and a channel outlet located in said upper portionof said end face, said mouth tube including a curved exterior surfacehaving a top side and a bottom side; and a pair of lip grooves that aresized and shaped so as to receive the lips of a patient and that arearranged on said curved exterior surface such that one lip groove islocated on said top side and the other lip groove is located oppositesaid first groove on said bottom side; wherein said mouth tube isfurther comprised of a pair of symmetrical halves, each havingcorresponding complementary connecting elements, wherein saidsymmetrical halves of said mouth tube are connected to one another by anintegral hinge; and wherein one of said symmetrical halves has a firstgroove segment and a second groove segment, and the other of saidsymmetrical halves has a third groove segment and a fourth groovesegment, said third groove segment cooperating with said first groovesegment to form said one lip groove, and said fourth groove segmentcooperating with said second groove segment to form said other lipgroove; and an atomizer path extending within said mouth tube from saidchannel inlet to said channel outlet, said atomizer path including afirst channel section and a second channel section, said first channelsection having at least one baffle and being in communication with saidchannel inlet and located at a first level, said second channel sectionbeing in communication with said first channel section and said channeloutlet; said second channel section including a first portion located atsaid first level, said first portion communicating with said firstchannel section and having a larger volume than said first channelsection, and a second portion located at a second level which is higherthan the first level, said second portion being in communication withsaid channel outlet of said mouth tube; and said channel outletincluding a horizontally oriented slit located in said upper portion ofsaid end face of said mouth tube.
 7. The mouthpiece according to claim6, wherein said mouthpiece is adapted for use with an inhaler foradministration of pharmacological dry powder.
 8. The mouthpieceaccording to claim 6, wherein said first channel section of saidatomizer path is formed by walls and said walls form said at least onebaffle.
 9. The mouthpiece according to claim 8, wherein said firstchannel section includes a plurality of baffles which protrude into saidatomizer path, thereby forming a plurality of curves within saidatomizer path.
 10. The mouthpiece according to claim 9, furthercomprising a ramp which is positioned at the channel inlet.